Multi-point tension distribution system device and method of tissue approximation using that device to improve wound healing

ABSTRACT

A tissue approximation device and processes for using the device are provided. The device is an implantable, biodegradable construct (except for hernia repairs) that has attachment points emanating from a supportive backing. The device improves the mechanical phase of wound healing and evenly distributes tension over the contact area between the device and tissue. Processes for using the device include wound closure, vascular anastomoses, soft tissue attachment and soft tissue to bone attachment.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This is a continuation-in-part of U.S. patent application Ser.No. 09/574,603 entitled “Multi-Point Tension Distribution System DeviceAnd Of Tissue Approximation Using That Device To Improve Wound Healing”filed May 19, 2000, now pending and incorporated herein by reference inits entirety.

FIELD OF THE INVENTION

[0002] This invention is in the field of surgery. More particularly, itrelates to a tissue approximation device that facilitates wound healingby holding soft tissue together under improved distribution of tensionand with minimal disruption of the wound interface and its nutrientsupplies. The device has multiple sites for grasping said tissue usingtines or prongs or other generally sharp, projecting points, extendingfrom a single, supportive backing. Various processes of using theinventive device are also a portion of the invention.

BACKGROUND OF THE INVENTION

[0003] The surgically induced healing of soft tissue wounds involves twophases the mechanical phase of wound closure followed by the biochemicalphase which involves protein bridging and scarring. In the mechanicalphase, the edges of soft tissue are held in contact by essentially twocomponents: 1) The physical properties and device-tissue interactions ofthe materials holding the tissue edges in contact, e.g. sutures orstaples; and 2) An early deposition of proteinaceous material that hasadhesive characteristics, e.g. fibrin glue.

[0004] Only in the biochemical phase, which occurs after the mechanicalphase, do tissue components replace the mechanical components adheringthe wound surfaces. During the biochemical phase, the inflammatorycascade generates signals which induce fibroblasts to migrate into thewound and synthesize collagen fibers.

[0005] Collagen is the primary constituent of connective tissue andultimately determines the pliability and tensile strength of the healingwound. Tensile strength is gradually recovered; 60% of ultimate woundstrength is achieved after approximately 3 months. However, this processis successful only if the previous mechanical phase has proceedednormally.

[0006] The surgeon's goal is to optimize the strength and often thecosmetic appearance of a wound closure or tissue coaptation. For this tohappen, tissue is mechanically approximated until the wound has healedenough to withstand stress without artificial support. Optimal healingrequires the application of appropriate tissue tension on the closure toeliminate dead space but not create ischemia within the tissue. Both ofthese circumstances increase the risk of wound infection and wounddehiscence.

[0007] Although the biomaterial composition of sutures has progressedconsiderably, the sophistication of manual suture placement in woundshas advanced relatively little since the original use of fabrics severalthousand years ago to tie wound edges together. The wide toleranceranges for suture placement, tension, and configurations, both amongstdifferent surgeons and for different implementations by the samesurgeon, result in a significant component of sub-optimal technique.Yet, the technique used for wound closure forms the foundation for allsubsequent events in the healing process. It is during this mechanicalphase that tissue tension is high, edema and inflammation are intense,wound edge ischemia is greatest, and that one can already observe thecomplication of wound failure.

[0008] Soft tissue is well known for its inability to hold tension. Evenwhen optimally placed, sutures gradually tear through soft tissue,producing gaps in wounds and possibly leading to the eventual failure orsub-optimization of wound healing. Furthermore, since sutures requirethe implementation of high levels of tension to counteract the forcesacting to separate tissues, they may strangulate the blood supply of thetissues through which they are placed, thus inhibiting the delivery ofwound nutrients and oxygen necessary for healing.

[0009] There have been many attempts to construct wound closure devicesthat decrease closure time and improve cosmesis. U.S. Pat. Nos.2,421,193 and 2,472,009 to Gardner; U.S. Pat. No. 4,430,998 to Harvey etal.; U.S. Pat. No. 4,535,772 to Sheehan; U.S. Pat. No. 4,865,026 toBarrett; U.S. Pat. No. 5,179,964 to Cook; and U.S. Pat. No. 5,531,760 toAlwafaie suggest such devices. However, these devices are not useful insurgical or deeper wounds. They only approximate the skin surface,joining skin edges variously through external approaches, usingadhesives or nonabsorbable attachment points that penetrate tissue. Thedevices minimally improve the biomechanics of wound closure, and do notadequately approximate the deeper layers of the closure, i.e. fascia ordermis. Externally placed attachment points that puncture the skinlateral to the wound also interfere with long-term cosmesis and providea possible conduit for infecting micro-organisms.

[0010] U.S. Pat. No. 5,176,692 to Wilk et al., discloses a device forhernia repair that utilizes mesh with pin-like projections to coverhernia defects. This device, however, is used in a laparoscopic herniarepair in conjunction with an inflatable balloon. Closure devices fordeeper tissues are described in U.S. Pat. No. 4,610,250 to Green; U.S.Pat. No. 5,584,859 to Brozt et al.; and U.S. Pat. No. 4,259,959 toWalker. However, these devices either work in conjunction with sutures,are made of materials that do not suggest biodegradability, or aredesigned in such a way as not to impart uniform tension on the closure,increasing the risk of wound separation and failure of wound healing.

[0011] The present invention is a biodegradable tissue approximationdevice. The device includes a plurality of attachment points, e.g.tines, prongs, or other generally sharp or blunt parts, connected to abacking that can be manipulated to close wounds, join soft tissue orbone, or create anastomoses. This multi-point tension distributionsystem (MTDS) device may be placed with minimal tissue trauma. Thepresent invention typically incorporates the deeper layers of tissuewithin the closure, and the multiple attachment points distribute theresulting tension, often uniformly. Approximation from the internalaspect of the wound minimizes the potential for dead space in theclosure, thus decreasing the risk of sub-optimal healing. Moreover,because the device is absorbed, a second procedure is not typicallyneeded to remove the device.

[0012] Thus, the present invention improves the mechanical phase ofhealing by facilitating wound closure and/or the coaptation of tissuesprior to initiation of the biochemical phase of wound healing. Placementof the device maximizes the chance for a good cosmetic result and is notheavily dependent on surgeon skill. Closure time is also shortened,decreasing overall cost and risk of operative complications.

SUMMARY OF THE INVENTION

[0013] The present invention is a device that improves the mechanicalphase of wound healing. In the preferred embodiment, tissue edges arestabilized by a plurality of attachment points that extend from asupportive backing. The density, shape, length, and orientation ofattachment points on the backing may be varied to suit the procedure,type of tissue being approximated, and/or area of the body involved.Moreover, various types of coatings may be selectively placed over thedevice to effect various responses. The flexibility of the backing isalso variable and dependent on the materials used and dimensions of thebacking. In the preferred embodiment, the device is biodegradable, andthe attachment points uniformly distribute tension over the contact areabetween the device and tissue.

[0014] Processes of using the present invention are also provided. Thedevice may be used to close wounds and create vascular anastomoses. Thedevice may also be manipulated to approximate soft tissue and softtissue to bone.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIGS. 1A-1D are plan, perspective views of various MTDS devices.

[0016] FIGS. 1E-1G are plan, perspective views of a MTDS device whichmay have various portions broken off to create a custom fitted device.

[0017] FIGS. 1H-1K are plan, perspective views of another variation onthe MTDS device which may also have various portions broken off tocreate a custom fitted device.

[0018] FIGS. 2A-2E are side views of various attachment point shapes andorientations.

[0019] FIGS. 3A-3D and 3F-3G are side views of various attachmentpoints.

[0020]FIG. 3E is a side view of a two-sided MTDS device.

[0021]FIG. 3H is a plan, reverse perspective view of nubs on theinferior surface of a MTDS device.

[0022]FIG. 4A is a side, cross-sectional view of attachment points thatrun through the width of a backing.

[0023]FIG. 4B is a side view of attachment points on a strip of backingmaterial.

[0024]FIG. 4C is a plan, perspective view of the embodiment in 4B on abacking.

[0025]FIG. 4D is a plan, perspective view of attachment points on asolid backing.

[0026]FIG. 5A is a plan, perspective view of attachment points canted inone direction.

[0027] FIGS. 5B-5D are plan, perspective views of attachment points withvarious orientations on a backing.

[0028]FIG. 5E is a side view of attachment points becoming progressivelyshorter the closer they are to the center of the device.

[0029]FIG. 5F is a side view of attachment points becoming progressivelyshorter the farther they are from the center of the device.

[0030] FIGS. 5G-5I are side views of backings and attachment pointswhich may be variously coated.

[0031] FIGS. 6A-6B are schematic views of a skin wound and wound repairusing the MTDS device.

[0032]FIG. 7 is a schematic view of an abdominal wound closure usingMTDS devices.

[0033] FIGS. 8A-8B are schematic views of an abdominal hernia and herniarepair using the MTDS device.

[0034] FIGS. 8C-8D are side and schematic views, respectively, of a MTDSdevice with attachment points on the edges of the backing and a centralarea without attachment points.

[0035] FIGS. 9A-9B are schematic views of a ruptured tendon and tendonto bone repair using the MTDS device.

[0036]FIG. 10A is an axial view of a cross-section of a vessel repairedwith the MTDS device.

[0037] FIGS. 10B-10C are side, schematic views of vessel free ends and avascular anastomosis using the MTDS device.

[0038] FIGS. 11A and 11B-11C are schematic, side, and cross-sectionalside views, respectively, of a transected tendon and a tendon to tendonrepair using the MTDS device.

[0039]FIG. 11D is an axial, cross-sectional view of the MTDS tendon totendon repair.

[0040]FIG. 11E is a side view of a vascular anastomosis using the MTDSdevice on the external surface of a vessel.

[0041] FIGS. 11F-11G are side, schematic views, and FIG. 11H is an axialview of the ends of a tubular structure being joined by externallyplacing strips of a MTDS device on approximated tissue.

[0042]FIG. 11I is an axial view of a hinge in the backing of a device.

[0043] FIGS. 11J-11K are axial views of decreased backing material thatare areas of enhanced device flexibility.

[0044] FIGS. 11L-11M are side views of a spring or coil-like MTDS devicebeing used to approximate tissue.

[0045]FIG. 11N is a plan, perspective view of a variation of the MTDSdevice having an optional locking mechanism.

[0046]FIG. 12A is a schematic view of the MTDS device being used in abrow-lift procedure.

[0047]FIG. 12B is a plan, perspective view of the MTDS device used in abrow-lift.

DETAILED DESCRIPTION OF THE INVENTION

[0048] Our inventive device may be used when working with bone anchorsor a variety of soft tissues. The device is of the generalconfigurations shown in FIGS. 1A-1B and comprises a plurality ofattachment points (102) emanating from a supportive backing (100) thatis a generally a porous material that may have the structure of a mesh,net, or lattice. The degree of flexibility of the backing is determinedby the material of construction, the shape and dimensions of the device,the type and properties of the approximated tissue, and the area of thebody into which the device is placed. For example, a tightly curved ormobile part of the body, e.g. a joint, will require a more flexiblebacking, as would a tendon or nerve repair due to the amount of bendingthe device needs for the attachment. Also, depending on the type ofmaterial used, the thickness of the backing as well as its width andlength may determine the flexibility of the device. Furthermore, thebacking may be pre-fabricated into different shapes as shown by thesharp corners (104) and rounded corners (106) in FIG. 1C and 1D. Thefabricated cross-sectional shape and dimensions of the mesh elements mayvary to promote flexibility in regions of the backing. Thecross-sectional shape of the mesh elements may be chosen to minimizelocal compressive stress between the backing and surface it rests upon,or have rounded and filleted edges to be less obtrusive to localcirculation. The plurality of attachment points distribute tension overthe contact area between the device and the tissue.

[0049]FIGS. 1E to 1G show variations of the device in which the backing(100) may be pre-fabricated into a standard shape with serrations orscore lines (108) formed throughout the backing (100). Serrations (108)may be formed by scoring the backing (100) to create regions orboundaries having a reduced cross-sectional area relative to other partsof the backing (100). These serrations (108) may then allow a physicianor surgeon to selectively break off portions of the backing (100) tocreate a device which is custom fitted for placement within specificregions of the body. Figure E shows one variation in which backing (100)has serrations (108) formed at regular intervals over the device. Priorto placement within the body, the physician may break off part of thebacking (100) along break line (110), as shown in FIG. 1F, to form adevice having a reduced area. Alternatively, as shown in FIG. 1G, thedevice of FIG. 1E may be selectively broken along break lines (112) forforming a device having a diamond shaped backing.

[0050]FIG. 1H shows another variation of a device in which the backing(100) may have serrations (114) formed diagonally along backing (100).Portions of the device of FIG. 1H may then be selectively broken off bythe physician to custom fit it for placement in different parts of thebody. For instance, FIG. 1I shows the corner portions (116) of FIG. 1Hhaving been removed along serrations (114). FIGS. 1J and 1K showalternative backing variations in which portions of the backing (100)have been selectively removed along serration (118) in FIG. 1J andoptionally along serration (120) in FIG. 1K. The geometry and placementof any of the serrations is not intended to be limited to the variationsdescribed herein, which are merely illustrative. The serrations, ifutilized, may be positioned along the backing (100) in an infinitevariety of geometries and locations and are dependent upon the desiredshapes which may be formed and regions within the body in which thedevice may be placed.

[0051] Materials such as biodegradable polymers are preferably used toconstruct the backing and attachment points. Polymers synthesized frommonomers comprising esters, anhydrides, orthoesters, and amides areparticularly suitable for biodegradation. Examples of biodegradablepolymers are polyglycolide, polylactide, poly-α-caprolactone,polydiaxanone, polyglyconate, polylactide-co-glycolide, and block andrandom copolymers of these polymers. Copolymers of glycolic, lactic, andother α-hydroxy acids are highly desirable. Although we prefer to use asingle polymer or copolymer in a specific device, generally for ease ofconstruction, the invention is not so limited. An example of aninventive device may be made of two or more types of polymers orcopolymers (or molecular weights of the same polymer or copolymer). Forinstance, the backing material might be produced from a more flexiblepolymer and the points or tines of a stiffer material. The inflammatoryresponse to these polymers is minimal, and they have been safely used insuture materials, stents, drug delivery devices, orthopedic fixationdevices, and intestinal anastomotic rings.

[0052] Generally, we will refer to the attachment points as “tines” or“prongs”. These tines will refer both to points which are either sharp,i.e. able to separate tissue in a chosen use, or blunt, i.e. not able toseparate tissue in that use. The attachment points may also be referredto as “barbs” when those points have the retaining point shown inseveral of the Figures discussed below.

[0053] As shown in FIGS. 2A-2E, the shape of the attachment points orbarbs may be varied depending, e.g., on the area of the body involvedand the type of tissue requiring closure or reapproximation. The tinesmay be canted or erect, but in a preferred variation, the generalstructure of the tines is of a rose thorn shape. The tines (200) have awide base (202) that supports a projection (204) from the backing (206)against the degree of tension required to close a wound or approximatetissue. For example, the attachment points may be erect tine (FIG.2B-208), canted tine (FIG. 2C-210), canted arrowhead (FIG. 2D-212),canted hook (FIG. 2E-214), or may have a single straight cross-section(FIG. 3G-311) that is nail-like, that does not vary over the length ofthe prong, for example, similar in shape to a nail or sharpened pencil.Furthermore, the tip of the attachment points may be varied as shown inFIGS. 3A-3D. The tips may be barbed (300), arrowhead (double-barb)(302), or cheese grater (304). A side view of the cheese grater tips isshown in FIG. 3D.

[0054] The connection of the prong to the backing may be rounded orfilleted, or the backing built-up around the prong, to reduce structuralstress concentrations. The backing or connecting structure may branchout away from the center, with each branch in turn branching to grappletissue in a distributed fashion. All edges of the device may be smoothexcept where sharpness is needed at the tip of the prong to pierce intothe tissue. Once the prongs pierce into the tissue, the tissue maybecome supported against the backing to minimize additional piercing orirritation by the prong tip. The device may be molded, stamped,machined, woven, bent, welded or otherwise fabricated to create thedesired features and functional properties.

[0055] The MTDS device may also have attachment points both on its frontside (305) and on a back side (307). As shown in FIGS. 3B and 3E, thefront and back sides have attachment points. The attachment points onthe front side (309) generally approximate tissue. The attachment pointson the back side (307) are auxiliary attachment points that may compriseforms such as round nubs (306) or pointed nubs (308). The auxiliaryattachment points may be used to secure or promote stable implantationof the device. Soft tissue may be gently pressed into open regions ofthe backing thereby helping to fix the device in place against bothunderlying and overlying tissue. FIG. 3H shows a reverse view of thenubs (310) on the back side of the device (312). The attachment pointson a two-sided device are not limited to the combinations disclosedabove, but may comprise any combination of the previously mentionedattachment point shapes and orientations.

[0056] Structural variations can also be made to the backing of thedevice. As shown in FIG. 4A, the attachment points (400) may be placedthrough a plurality of openings in the backing (402) and secured to thebacking by a flange (404) or hub. In FIGS. 4B and 4C, the points (406)may also connect to strips (408) of the same material as the attachmentpoints which are then secured to a backing (410). The backing may alsobe comprised of a solid material (412) instead of a porous material.

[0057] The extent of porosity, or total surface area may be used tocontrol the absorption rate of the device, and may also be used tooptimize the strength-to-mass properties of the device, increasing thesection modulus of structural cross-sections per unit mass. The backingstructure may comprise partial folds, waves or grooves to help holdtissue against both surfaces of the backing. Regions of the backing mayfunction as suction cups to help hold tissue to the backing.

[0058] The density, distribution, length, and orientation of attachmentpoints on the backing may be modified depending on the type of woundclosure. Attachment points may be bent or curve gradually, with the tipdirected at an optimal angle relative to the backing to aid devicepenetration and stability within the tissue, and to reduce tissueirritation after device installation. Attachment points may be canted inone direction (500), such as toward the center of the device as shown inFIG. 5A. The attachment points may also be variously oriented, such astoward center (502) and erect (504), or toward center (502) and awayfrom center (506). It is within the scope of this invention to haveattachment points extending in any relative direction or orientation onthe backing. Or, as shown in FIG. 5D, the backing is divided into afirst area (508) and a second area (510). Attachment points in the firstarea (512) and second area (514) are canted toward each other. Theinventive device may also be sectioned into a plurality of areas, witheach section being variously oriented to another section.

[0059] In another variation of the invention, attachment points ofvarious lengths emanate from a single backing. For example, in FIG. 5E,the attachment points (515) are progressively shorter the closer theyare to the center of the device (516). The attachment points (515) mayalso become progressively shorter the farther they are from the centerof the device as shown in FIG. 5F. The variations shown in FIGS. 5B and5C have regions of attachment points canted toward the center (502) andwith other regions of attachment points with erect points (504 in FIG.5B) or canted away from the other end (506 in FIG. 5C) of the device.These variations are more difficult to dislodge when situated in an areaof the body having both to-and-fro movement, e.g., the inside of anelbow or back of the knee, or during placement of the device.

[0060]FIGS. 5G to 5I show yet another variation of the invention inwhich various coatings (518) may be selectively placed over the device.FIG. 5G shows one representative variation in which a coating (518) maybe placed over the entire device, including the backing (206) and tines(200). Alternatively, coating (518) may be placed only upon a singlesurface, e.g., the surface upon which tines (200) are located, or alongthe back surface only. FIG. 5H shows another variation in which thecoating (518) may be placed only upon the tines (200). The coating (518)may be selectively placed over all the tines (200) or only over aselective number of tines (200) depending upon the desired results. FIG.5I shows yet another variation in which the coating (518) may be placedonly upon the backing (206) and omitted from the tines (200). Thecoating (518) in this variation may be placed upon both surfaces ofbacking (206) or only upon a single surface depending upon the desiredresults.

[0061] The type of coatings (518) placed upon the device may varydepending upon the desired results. For instance, one type of coating,e.g., fibrin, cyanoacrylate, etc., may be used to increase adhesion ofthe device or to act as an anchoring mechanism for the device to thetissue or bone surface, another type may be used to encourage or enhancethe growth of the bone upon or within which the device is placed, e.g.,bone matrix protein. Various coatings may also be used to create alubricious surface over the device to facilitate its insertion withinthe tissue or bone. Another type of coating made from, e.g., fibroblastgrowth factors, may be used to enhance the healing of the wound or acoating made with, e.g., lidocaine, may also be an analgesic to reduceany accompanying pain. Another type of coating may be used on the deviceto promote the biocompatibility of the device and to reduce the risk ofrejection by the body. To enhance the healing of the wound as well as topromote the biocompatibility of the device, the coating made from, e.g.,aminoglycoside, may additionally have anti-viral and anti-bacterialproperties.

[0062] Alternatively, other coating variations made from, e.g.,corticosteroids, may be used to prevent or manipulate, i.e., minimize,any resulting scars, accelerate degradation of the underlying backing,or alternatively to enhance the structural strength of the device, i.e.,materials such as linear polymers which increase the tensile strength ofthe device. Moreover, another coating variation having a high surfaceroughness may be coated over the device to provide an increasedroughened area for facilitating tissue and bone in growth as well ashelping to prevent slippage of the device. Any of the preceding coatingswhich may be utilized may include any types of coating materials asconventionally known and used in the art.

[0063] Portions of simple wound closures are shown in FIGS. 6A-6B. Thesewound closures involve placing the MTDS device (600) at the bottom ofthe wound, usually at the level of the sub-dermis (602). The edges ofthe wound (604) are approximated and then secured by fixation, e.g., bypressing, to the multiple attachment points (606). An example of theMTDS device placement in a laparotomy closure is shown in FIG. 7. Theincreased length of this incision requires placement of multiple devices(700).

[0064] A unique application of this device occurs in hernia repair inwhich case the biomaterials are not absorbable but rather are morelikely to be PTFE and POPU (“Gore-Tex”), polypropylene, or otherpermanent implant material. Once the hernia (801) is reduced, a MTDSdevice may be used to close the hernia defect by joining the edges ofthe separated fascia (804) as seen in FIGS. 8A and 8B. However, thedevice may also be modified to aid repair of a difficult herniaresulting from such circumstances as operating on an obese patient orlarge hernia, or having a wide fascial debridement where the fascialedges cannot be brought together. FIGS. 8C and 8D are variations of theinventive device that may be used in these cases. The attachment points(800) are secured to the ends of the backing (806) and are still used toadhere the device to tissue, but the points are spaced so that thecentral area of the backing is a flat surface without points (802) thatcovers the defect. The device in FIG. 8D is preferably used in anincisional hernia repair.

[0065] The MTDS device may also be constructed to reattach soft tissuesuch as tendons and ligaments to bone, as well as other soft tissue suchas cartilage and the free ends of vessels or nerves. In FIG. 9A, theinventive device functions similar to a clamp. Backings with attachmentpoints (900) are sides of a clamp that has a first end (901) and asecond end (904). The first end (901) grasps tissue and the second end(904) is an anchor for tissue. For example, a ruptured tendon (906) maybe fixed to the attachment points (908) of the first end of the clamp(901) and approximated to bone (902) with an anchor such as a pin ornail at the second end of the clamp (904), as seen in FIG. 9B. Aftermechanical fixation of the tissues, the biochemical phase of the woundhealing process will begin, eventually forming a natural union betweentendon and bone. Ligament and cartilage to bone unions using the MTDSdevice would undergo the same mechanical and biochemical processes.

[0066] Vascular anastomoses may also be constructed with the MTDSdevice. In FIG. 10B, the backing has a tubular shape (1000) withattachment points (1001) on the outside surface (1002). The outsidesurface (1002) has a first end (1003) and a second end (1005) thatopposes the first end (1003). The free ends of a vessel(s) (1004) areplaced over the device, creating an anastomosis (1006) that is securedby attachment points fixed into the wall of the vessels (1008). Theattachment points are preferably pointing towards the anastomosis(1006), with the attachment points on the first end (1003) being cantedtoward the second end (1005) and vice-versa. An axial view of therelationship of the attachment points (1010) to the vessel wall (1012)is shown in FIG. 10A.

[0067] Vessels and other soft tissue such as nerves, cartilage, tendons,and ligaments may also be joined as seen in FIGS. 11A and 11B. Two endsof tissue (1100) are brought and held together by the backing andattachment point construct (1102) being wrapped around the circumferenceof the tissue (1104). The attachment points (1106) are on the insidesurface of the backing (1107) and secure the union at a central region(1108) as seen in FIG. 11C. An axial, cross-sectional view of therelationship between the attachment points (1110) and tissue (1112) isshown in FIG. 11D. The resulting form is, i.e., a tubular structure thathas an inside surface (1107) with a central region (1108). Theattachment points on the inside surface (1106) are canted toward thecentral region (1108). FIG. 11E shows the device with attachment points(1101) on the inside surface of the backing (1103) being wrapped aroundvessel ends to create an anastomosis (1105). Instead of being wrappedaround tissue, edges (1113) of tubular structures (1115) can also bejoined by externally placing 2 or more strips of backing of a MTDSdevice (1114) on approximated tissue as shown in the side views of FIGS.11F-11G, and the axial view in FIG. 11H. The attachment points (1117)also point toward the area of tissue approximation (1116).

[0068] FIGS. 11I-11M are additional variations of the invention whichvary the mechanisms used to improve device flexibility. In FIGS.11I-11K, the backing has areas of comparatively higher flexibility thanother areas of the backing. In an axial view of the variation in FIG11I, the backing is equipped with hinges (1118) that allow bending ofthe backing (1120) around tubular soft tissue structures (1115). In asecond variation, the amount of material in the areas of the device thatfold (1122) is reduced as shown in FIGS. 11J-11K. Another variation isseen in FIGS. 11L-11M where attachment points (1124) of a device extendfrom a backing in the form of a coil or spring (1126). The edges of softtissue are approximated when the coil or spring is reduced (1128).

[0069]FIG. 11N shows yet another variation of the invention. As shown,the device has a backing (1120) which has a plurality of tines (1124)defined on an inner surface (1130) of the device. The device preferablyincludes a hinge region (1132) defined along the backing (1120), whichmay be a hinge as described above, and may also include a reduced area(1134) within the hinge region (1132) about which the backing (1120) maybend. This variation may be placed around tubular structures (1115) bywrapping backing (1120) about the hinge region (1132) such that thetines (1124) point inwardly towards the newly created lumen (1138) andadhere to the tissue. As such, this variation preferably has the backing(1120) formed into two semi-circular halves. To prevent the device fromslipping off the tubular structure (1115), an optional locking mechanism(1136) may be placed at or along the edges of the device such that themechanism (1136) is able to lock to itself when wrapped about a tubularstructure (1115). Such a locking mechanism (1136) may include any numberof conventional mechanical fasteners, e.g., clasps, hooks, keyed edges,screws, biocompatible adhesives, etc.

[0070] The MTDS device may also be used in soft-tissue remodeling, suchas a brow-lift, shown in FIG. 12A. After dissection of the scalp (1200),the anterior scalp flap (1202) may be raised over the attachment points(1204) to lift the brow (1206). The ends of both the anterior flap(1202) and posterior flap (1208) may then be trimmed and fixed onto theattachment points (1204) to close the wound. The device may be securedto the skull (1210) by a screw (1212). Alternatively, the device may besecured to the skull by a post (1220) rather than a screw (1212). Thepost (1220) may be comprised of a bioabsorbable material, as describedabove, or it may be made of a biocompatible metal or alloy, e.g.,stainless steel. The outer surface may be non-threaded and smooth or itmay define grooves or projections thereon to aid in maintaining the post(1220) within the skull. In either case, post (1220) may be insertedwithin the skull and held in place via friction fitting or interferencefitting where the diameter of the hole within the skull is slightlysmaller than the overall diameter of the post (1220). The post (1220)may also have a cross-sectional shape or area which is non-uniform alongits length. For instance, the post cross-section may decrease oralternatively increase along its length. It may also have a reduced orenlarged cross-sectional shape or area near the central portion of thepost. Moreover, although a single post (1220) is shown in the figure,any number of anchors may be utilized as practicable extending throughor from the supportive backing. For example, two posts may be utilizedpositioned adjacent to one another or at opposite ends along thebacking, depending upon the desired results. The inventive device inthis example may have a first end (1214) and a second end (1216), thefirst end having a first area (1215) and the second end having a secondarea (1217). The first area (1215) and second area (1217) may haveextending attachment points (1204) or one or more openings (1218) toaccommodate a screw(s) (1212). The second area attachment points arecanted toward the first end of the device as shown in FIG. 12B.

[0071] We have described this invention by example and by description ofthe physical attributes and benefits of the structure. This manner ofdescribing the invention should not, however, be taken as limiting thescope of the invention in any way.

I claim as my invention:
 1. An implantable device for placement on atissue surface and interior to an exterior tissue surface comprising: a)a biodegradable supportive backing which defines at least one serratedboundary thereon, the backing having: i.) at least a first area with aplurality of biodegradable attachment points extending from the firstarea for attaching to a selected tissue and ii.) a second area discretefrom the first area, wherein the backing has physical characteristicssufficient to approximate or to support the selected tissue adjacent thefirst area with respect to the second area, and b) the plurality ofbiodegradable attachment points extending from the first area, whereinthe plurality of biodegradable attachment points are configured toattach to the selected tissue and to distribute tension between thefirst area and the selected tissue.
 2. The implantable device of claim 1wherein the supportive backing is adapted to separate along the serratedboundary.
 3. The implantable device of claim 1 wherein the supportivebacking further defines a plurality of serrated boundaries thereon. 4.The implantable device of claim 3 wherein at least one of the pluralityof serrated boundaries is defined diagonally relative to the remainingboundaries.
 5. The implantable device of claim 1 further comprising alocking mechanism attached to or near at least a first edge of thebacking, wherein the locking mechanism is adapted to couple to a secondedge of the backing and engagingly hold the first and second edges toone another.
 6. The implantable device of claim 5 wherein the lockingmechanism is selected from the group consisting of clasps, hooks, keyededges, screws, and biocompatible adhesives.
 7. The implantable device ofclaim 1 wherein said biodegradable supportive backing comprises a solidmaterial.
 8. The implantable device of claim 1 wherein saidbiodegradable supportive backing and said plurality of biodegradableattachment points comprise a polymer or copolymer.
 9. The implantabledevice of claim 8 wherein said polymer or copolymer comprises one ormore materials selected from the group consisting of polyglycolide,polylactide, poly-α-caprolactone, polyglyconate,polylactide-co-glycolide, their mixtures, alloys, and random and blockcopolymers.
 10. An implantable device for placement on a tissue surfaceand interior to an exterior tissue surface comprising: a) abiodegradable supportive backing having: i.) at least a first area witha plurality of biodegradable attachment points extending from the firstarea for attaching to a selected tissue and ii.) a second area discretefrom the first area, wherein the backing has physical characteristicssufficient to approximate or to support the selected tissue adjacent thefirst area with respect to the second area, b) the plurality ofbiodegradable attachment points extending from the first area, whereinthe plurality of biodegradable attachment points are configured toattach to the selected tissue and to distribute tension between thefirst area and the selected tissue, and c) a coating at least partiallycovering the implantable device.
 11. The implantable device of claim 10wherein the coating selectively covers at least a single surface of thesupportive backing.
 12. The implantable device of claim 10 wherein thecoating selectively covers at least one of the biodegradable attachmentpoints.
 13. The implantable device of claim 10 wherein the coatingcomprises an adhesive material adapted to increase adhesion between theimplantable device and the tissue surface.
 14. The implantable device ofclaim 10 wherein the coating comprises a material adapted to encouragebone growth.
 15. The implantable device of claim 10 wherein the coatingcomprises a lubricious material.
 16. The implantable device of claim 10wherein the coating comprises a material adapted to enhance healing ofthe selected tissue.
 17. The implantable device of claim 16 wherein thematerial is further adapted to have anti-viral and anti-bacterialproperties.
 18. The implantable device of claim 10 wherein the coatingcomprises an analgesic material.
 19. The implantable device of claim 10wherein the coating comprises a material adapted to promotebiocompatibility of the implantable device.
 20. The implantable deviceof claim 19 wherein the material is further adapted to have anti-viraland anti-bacterial properties.
 21. The implantable device of claim 10wherein the coating comprises a material adapted to accelerate adegradation of the biodegradable supportive backing.
 22. The implantabledevice of claim 10 wherein the coating comprises a material having ahigh-tensile strength.
 23. The implantable device of claim 10 whereinthe coating comprises a material having a high surface roughness.
 24. Animplantable device for placement on a tissue surface and interior to anexterior tissue surface comprising: a) a biodegradable supportivebacking having: i.) at least a first area with a plurality ofbiodegradable attachment points extending from the first area forattaching to a selected tissue, ii.) a second area discrete from thefirst area, and iii.) a hinge region, wherein the backing has physicalcharacteristics sufficient to approximate or to support the selectedtissue adjacent the first area with respect to the second area, and b)the plurality of biodegradable attachment points extending from thefirst area, wherein the plurality of biodegradable attachment points areconfigured to attach to the selected tissue and to distribute tensionbetween the first area and the selected tissue, and c) a lockingmechanism attached to or near at least a first edge of the backing,wherein the locking mechanism is adapted to couple to a second edge ofthe backing and engagingly hold the first and second edges to oneanother while.
 25. The implantable device of claim 24 wherein thesupportive backing is adapted to bend about the hinge region when thefirst and second edges are coupled together.
 26. The implantable deviceof claim 24 wherein the hinge region comprises an area having a reducedcross-section about which the hinge region bends.
 27. The implantabledevice of claim 24 wherein the supportive backing forms at least twosemi-circular halves adapted to bend about the hinge region.
 28. Theimplantable device of claim 24 wherein the locking mechanism is selectedfrom the group consisting of clasps, hooks, keyed edges, screws, andbiocompatible adhesives.
 29. An implantable device for placement on atissue surface and interior to an exterior tissue surface comprising: a)a biodegradable supportive backing having: i.) at least a first areawith a plurality of biodegradable attachment points extending from thefirst area for attaching to a selected tissue and ii.) a second areadiscrete from the first area, wherein the backing has physicalcharacteristics sufficient to approximate or to support the selectedtissue adjacent the first area with respect to the second area, and b)the plurality of biodegradable attachment points extending from thefirst area, wherein the plurality of biodegradable attachment points areconfigured to attach to the selected tissue and to distribute tensionbetween the first area and the selected tissue, and c) at least oneanchoring member defined on the supportive backing and adapted to holdthe supportive backing to the tissue surface.
 30. The implantable deviceof claim 29 wherein the anchoring member comprises a screw.
 31. Theimplantable device of claim 29 wherein the anchoring member comprises apost.
 32. The implantable device of claim 31 wherein the post has asmooth outer surface.
 33. The implantable device of claim 31 wherein thepost has a non-uniform cross-sectional shape.
 34. The implantable deviceof claim 31 wherein the post defines projections on an outer surface formaintaining the device.
 35. The implantable device of claim 29 whereinthe anchoring member comprises a biodegradable material.
 36. Theimplantable device of claim 35 wherein the biodegradable materialcomprises a polymer or copolymer.
 37. The implantable device of claim 36wherein said polymer or copolymer comprises one or more materialsselected from the group consisting of polyglycolide, polylactide,poly-α-caprolactone, polyglyconate, polylactide-co-glycolide, theirmixtures, alloys, and random and block copolymers.
 38. The implantabledevice of claim 29 wherein the anchoring member comprises abiocompatible metal.
 39. The implantable device of claim 29 wherein anouter surface of the anchoring member is smooth.
 40. The implantabledevice of claim 29 wherein an outer surface of the anchoring memberdefines a plurality of grooves or projections.
 41. The implantabledevice of claim 29 wherein the supportive backing comprises a pluralityof anchoring members.